Pediatric Prehospital Airway Resuscitation Trial (Pedi-PART)

This study is a Phase 3, multi-center, Bayesian Adaptive Sequential Platform Trial testing the effectiveness of different prehospital airway management strategies in the care of critically ill children. Emergency Medical Services (EMS) agencies affiliated with the Pediatric Emergency Care Applied Research Network (PECARN) will participate in the trial. The study interventions are strategies of prehospital airway management: [BVM-only], [BVM followed by SGA] and [BVM followed by ETI]. The primary outcome is 30-day ICU-free survival. The trial will be organized and executed in two successive stages. In Stage I of the trial, EMS personnel will alternate between two strategies: [BVM-only] or [BVM followed by SGA]. The [winner of Stage I] will advance to Stage II based upon results of Bayesian interim analyses. In Stage II of the trial, EMS personnel will alternate between [BVM followed by ETI] vs. [Winner of Stage I].

Study Overview

• Status: Not yet recruiting
• Conditions: Wounds and Injuries; Critical Illness; Child, Only; Heart Arrest, Out-Of-Hospital; Respiratory Insufficiency in Children
• Intervention / Treatment: Device: BVM; Device: SGA; Device: ETI

Detailed Description

Cardiac arrest, respiratory failure, and major trauma are devastating critical conditions in children. Resuscitation from critical illness requires skillful airway management to optimize the delivery of oxygen to the lungs, preventing irreparable damage to the brain and heart. As the first to provide resuscitation care for critically ill children, prehospital EMS personnel are often the first to perform life-saving airway management.

The most common prehospital airway management techniques (bag-valve-mask ventilation [BVM], endotracheal intubation [ETI], and supraglottic airway insertion [SGA]) have important trade-offs between risks and benefits. Despite the challenges of ETI and national recommendations favoring BVM, many EMS personnel favor ETI over BVM. Newer SGA devices such as the laryngeal tube (LT), laryngeal mask airway (LMA), and i-gel® have not been compared with other techniques in children. National organizations, including the Agency for Healthcare Research and Quality, have declared the need for new, rigorous trials of all techniques to determine the best strategies for prehospital airway management in children. Interviews with front-line EMS personnel underscore the dire need for clear and strategic guidelines for managing the pediatric airway.

The Pediatric Prehospital Airway Resuscitation Trial (Pedi-PART) will determine the best strategies for prehospital airway management in critically ill children. The trial aims are Aim I-Primary Objective (Effectiveness)-Stage I: Determine if [BVM-only] or [BVM followed by SGA] results in better ICU-free survival in critically ill children with cardiac arrest, major trauma, or respiratory failure. Stage II: Determine if [winner of Stage I] or [BVM followed by ETI] results in better ICU-free survival. Bayesian analyses will determine the transition from Stage I to Stage II, ensuring optimal deployment of available subjects to address the postulated questions. Aim 2- Secondary Objective (Safety)-Stage I: Determine if [BVM followed by SGA] results in fewer prehospital and hospital safety events compared with [BVM-only] in critically ill children with cardiac arrest, major trauma, or respiratory failure. Stage II: Determine if the winner of Stage I results in fewer safety events compared with [BVM followed by ETI].

The trial will use a Bayesian Adaptive Sequential Comparison Platform Trial (BASiC-PT) design and will be executed in two sequential stages. Stage I: Determine if [BVM-only] or [BVM followed by SGA] results in better ICU-free survival in critically ill children with cardiac arrest, major trauma, or respiratory failure. Stage II: Determine if [winner of Stage I] or [BVM followed by ETI] results in better ICU-free survival. Bayesian analyses will determine the transition from Stage I to Stage II, ensuring optimal deployment of available subjects to address the postulated questions.

• Study Type: Interventional
• Enrollment (Estimated): 3000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Henry E Wang, MD, MS; Phone Number: 614-293-8305; Email: henry.wang@osumc.edu
• Study Contact Backup: Name: Jennifer Frey, PhD; Phone Number: 614-293-8305; Email: jennifer.frey2@osumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion criteria are:

• At least 24 hours old and <18 years old
• Cardiopulmonary arrest, major trauma or respiratory failure
• Life-saving care initiated or continued by Pedi-PART EMS personnel as part of an emergency "9-1-1" response
• Requiring active airway management (BVM or higher level of respiratory support

Exclusion criteria are:

• Prisoners
• Pre-existing tracheostomy
• Pre-existing do-not-resuscitate/do-not-intubate status
• Visibly or known to be pregnant
• Initial advanced airway attempt by an EMS agency not affiliated with the study
• Interfacility transports

EMS personnel will use bystander reports or follow local protocols to establish patient age and pregnancy status.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: BVM-only; Initial strategy of airway management using Bag-Valve-Mask (BVM) only.	Device: BVM; Bag-Valve-Mask Ventilation
Active Comparator: BVM followed by SGA [BVM+SGA]; Initial strategy of airway management using Bag-Valve-Mask (BVM) followed by Supraglottic Airway (SGA).	Device: BVM; Bag-Valve-Mask Ventilation; Device: SGA; Supraglottic Airway
Active Comparator: BVM followed by ETI [BVM+ETI]; Initial strategy of airway management using Bag-Valve-Mask (BVM) followed by Endotracheal Intubation (ETI).	Device: BVM; Bag-Valve-Mask Ventilation; Device: ETI; Endotracheal Intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day ICU-free survival	The number of days in the first 30 days after the treatment event where: 1) the patient was not known to have died; and 2) the patient was not hospitalized in the intensive care unit. ICU admission/discharge criteria will not be standardized.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurologic outcome upon hospital discharge	Outcome will be measured with Pediatric Cerebral Performance Category score (PCPC - 1 = normal, 2 = mild disability, 3 = moderate disability, 4 = severe disability, 5 = coma or vegetative state, 6 = dead).	Identified through end of study but no later than 30 days after final enrollment.

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); University of Utah
• Investigators: Principal Investigator: Henry E Wang, MD, MS, Ohio State University

Publications and helpful links

General Publications

• Bosson N, Hansen M, Gausche-Hill M, Lewis RJ, Wendelberger B, Shah MI, VanBuren JM, Wang HE. Design of a novel clinical trial of prehospital pediatric airway management. Clin Trials. 2022 Feb;19(1):62-70. doi: 10.1177/17407745211059855. Epub 2021 Dec 7.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): September 30, 2029

Study Registration Dates

• First Submitted: April 9, 2024
• First Submitted That Met QC Criteria: April 11, 2024
• First Posted (Actual): April 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: children; airway management; respiratory insufficiency; heart arrest; injuries; emergency medical services; intubation, intratracheal
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Disease Attributes; Respiratory Insufficiency; Wounds and Injuries; Critical Illness; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: 2023X0135; UG3HL165019 (U.S. NIH Grant/Contract); U24HL165014 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes